The following data is part of a premarket notification filed by Roydent Dental Products, Inc. with the FDA for Core-ide.
Device ID | K984037 |
510k Number | K984037 |
Device Name: | CORE-IDE |
Classification | Coating, Filling Material, Resin |
Applicant | ROYDENT DENTAL PRODUCTS, INC. 1010 WEST HAMLIN RD. Rochester Hills, MI 48309 |
Contact | Donald A Leroy |
Correspondent | Donald A Leroy ROYDENT DENTAL PRODUCTS, INC. 1010 WEST HAMLIN RD. Rochester Hills, MI 48309 |
Product Code | EBD |
CFR Regulation Number | 872.3310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-11-12 |
Decision Date | 1999-02-04 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CORE-IDE 75479880 not registered Dead/Abandoned |
Roydent Dental Products, Inc. 1998-05-05 |
CORE-IDE 74338922 not registered Dead/Abandoned |
ROYDENT DENTAL PRODUCTS, INC. 1992-12-10 |